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Remember, MOS data has been pushed back in the timeline until, perhaps the fall. Part wring has been pushed back as far as the spring. The only news of the day is old news - the IST. So I expect a drop. A few things that could help - a better than expected boost in AVID revenue; an indication that they intend to apply for AA, clarification on the MOS status in the front-line trial (assuming it's positive). Otherwise, news hole and the shorts get more time to cover.
Somebody should ask the AA question this afternoon.
Also note Mojojo's post #83416 and compare the numbers in the last section to our ORR numbers published on May 21st.
I believe Phase IV simply means it's a confirmatory trial.
I now expect Peregrine to file for AA, based on Mojojo's find.
You can get AA before a PIII.
http://jnci.oxfordjournals.org/content/95/18/1351.full
...U.S. Food and Drug Administration (FDA) approval of oncology drugs called “accelerated approval.” This mechanism, first used in 1995, allows approval based on a surrogate endpoint considered reasonably likely to predict patient benefit (2). Thus, because clear evidence of patient benefit is not required, accelerated approval is inevitably based on evidence that is less than sufficient to grant full approval. The majority of the more than 20 accelerated approvals granted to date have been based on the results of phase II trials.
Fast Track vs. Accelerated Approval vs. Priority Review
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
We did beat those numbers Wook.
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=675168
Nice find, MJ!
http://finance.yahoo.com/news/avid-bioservices-announces-addition-novel-203000719.html
"Phage's manufacturing process improves upon well-established approaches for the manufacture of targeted proteins and results in production of properly folded, soluble therapeutic proteins, at high yields. We believe this will be a great asset to Avid's already comprehensive list of service offerings."
Got it. :o)
I don't think they can file for FDA approval without being stat. sig. and, if so, AA would be off the table.
Of course, we could make it to 20 months. In our PII for Advanced and Metastatic Breast Cancer, where the treatment arm was also docetaxel and bavituximab, MOS was 20.7 months.
Significance Calculator
I've been playing around with some online statistical calculators. I'm sure I'm doing it all wrong.
BUT, not to be deterred, (in case there are things I can learn),
Using one calculator, I got that we need the treatment arm to reach MOS 20 months to reach statistical significance.
I'm not sure that it will matter as ORR and PFS were our two prespecified endpoints. Neither ORR nor PFS, from my calc (and I emphasize, I do not whereof I speak biostatistically) were stat. sig..
Which suggests, to my great disappointment, that AA is not in the cards.
Fortunately, I most assuredly screwed up the calculations completely. Anybody who knows what the hell they're actually doing want to give it a stab?
:o)
Slide 27
Integrated cGMP biomanufacturing enables us to be Phase III and commercial-ready for bavituximab, Cotara.
Really?
New cases NSCLC in the USA in 2012: 226,160
http://www.cancer.gov/cancertopics/types/lung
If bavi ultimately improves MOS on the SOC for both 1st and 2nd-line NSCLC as much as we think it might, what are the chances that AVID has the capacity to produce enough bavituximab to satisfy US demand?
If and when PPHM decides to apply for AA, IMO, you will see an immediate, dramatic move to expand manufacturing.
Something to watch for...
Try this one instead.
http://www.who.int/mediacentre/factsheets/fs297/en/index.html
Extensive free resource of cancer statistics world wide.
Speaking as one of the lately unwashed, welcome home!
Anybody rich yet? For only £3648!
I would if I could...
Epidemiology: Non-Small Cell Lung Cancer – Despite global efforts to stop smoking, incidence rates will remain unchanged
Health Statistics : Non-Small Cell Lung Cancer – Despite global efforts to stop smoking, Market Overview in cidence rates will remain unchanged
Publication date: November 2011
http://www.reportlinker.com/p0760640-summary/Epidemiology-Non-Small-Cell-Lung-Cancer-Despite-global-efforts-to-stop-smoking-incidence-rates-will-remain-unchanged.html
Introduction
Smoking is the leading cause of lung cancer, responsible for 95% of all cases. Global efforts to stop smoking have stabilized over the last decade. Datamonitor epidemiologists expect the number of total incident cases of non-small cell lung carcinoma to remain stable in the seven major markets over the next 10 years.
Features and benefits
* Gain insight into market potential, including a robust 10-year epidemiology forecast of non-small cell lung cancer.
* Understand the key epidemiologic risk factors associated with non-small cell lung cancer.
Highlights
Most people are not diagnosed with lung cancer until the disease has advanced to later-stage illness, making it difficult to treat the cancer successfully and greatly impacting 5-year survival rates for the disease. Smoking cessation is the most effective measure in reducing the risk of non-small cell lung cancer.
For newly diagnosed non-small cell lung cancer in the seven major markets, adults aged 70–74 will have the largest number of total incident cases (80,310 cases), followed by adults ages 65–69 and 75–79 (73,500 cases and 71,300 cases, respectively).
Your key questions answered
* What are the most robust sources for non-small cell lung cancer incidence data?
* How will the patient population change through to 2020 in the US, Japan, and the five major EU markets (France, Germany, Italy, Spain, and the UK)?
* How do changes in population structure and risk factors affect the trend in incident non-small cell lung cancer cases?
###
Going to KT's point, I'll bet they're strategizing the split of the NSCLC pie knowing the facts and analysis in this (kind of) report.
To get a sense of how much is at stake (and why the shitheads will never relent), ask yourselves this:
For how many cancers will bavi gain approval? How many second gen and third gen iterations of the PS, PE platform will make it to market? Will they ever market bavi or an iteration for infectious disease (envelope viruses). What is imaging worth? Cotara?
How much revenue will all that turn into.
How much market value will all that turn into?
Personally, in a few years, I put the buyout somewhere out in the stratosphere.
The thing about shithead shareholders, they never learned to share. Money is blood sport.
HuffPost let it run.
Must have been the support of my few but passionate fans... :o)
http://www.huffingtonpost.com/2012/07/13/russell-wasendorf-sr-peregrine-financial-group_n_1671740.html
10 Fans
37 minutes ago ( 9:45 AM)
For those who may be confused, Peregrine Financial is NOT Peregrine Pharmaceuticals. The financial company is a mess. The pharmaceutical company is riding high (up over 100% in the last month) on anticiaption of possibly extraordinary survival data coming out of their nonsmall cell lung cancer clinical trial.
Left a comment on Huff re: the PF article:
For those who may be confused, Peregrine Financial is NOT Peregrine Pharmaceuticals. The financial company is a mess. The pharmaceutical company is riding high (up over 100% in the last month) on anticiaption of possibly extraordinary survival data coming out of their nonsmall cell lung cancer clinical trial.
We'll see if the moderators let it run...
:o)
Maybe they could cook their own yew trees and gemcitabine. If they can address multiple stages of multiple cancers (10, 20, 30?) worldwide, it might make financial sense.
:o)
News that actually gets it right, even if the emphasis isn't quite right.
http://www.smallcapnetwork.com/Stock-Holds-Spike-Q4-FY-2012-Due-Monday-NASDAQ-PPHM/s/via/14/article/view/p/mid/1/id/892/
Loof, this bullshit's been going on for a decade. Heads never roll. That's why, as a long, you have to be defensive. That's why margin is so dangerous. Wait until they find a chink in the data. The board will fill with Moby-like posters. By sheer volume they will drown out every other voice on the board.
Think the misspelling was an accident? I don't. Nastier and nastier. There will be no end to it.
Just going to get nastier.
Issue of malicious intent. Don't think it's likely to go anywhere. Hard to prove. Would have to have a paper trail.
I called Gekko a moron. Doesn't look like it went public. Anyway, can't be sued for liable, I'd have to be misrepresenting the facts...
Who cares what the stock does today or Monday. The weighing machine will take over eventually. The slow but steady hare wins this race.
BTW, anybody using stop-losses? Bear raids like these are just beginning. Stop-losses, in this case, could be termed profit give-aways. (Gekko & Co. probably trying to scoop up your shares.) Anybody witness the DNDN bear raid? Would have taken your breath away.
I just loved the last line. After describing a train wreck: Shares of Peregrine Pharmaceuticals are trading 11.23% higher today.
They must not read what they write... ;o)
This has to be a comedy site like The Onion:
http://wallstcheatsheet.com/stocks/peregrine-missing-215m-and-4-hot-stocks-making-waves.html/
Peregrine Pharmaceuticals (NASDAQ:PPHM) has a plethora of problems. Following the suicide attempt Monday by the founder of the company, regulators discovered that nearly $215 million of customer money was gone. Fraud was charged in a lawsuit filed by The Commodity Futures Trading Commission, and criminal authorities continue to investigate. Peregrine has already filed for bankruptcy and shut down. Shares of Peregrine Pharmaceuticals are trading 11.23% higher today.
Fab. :o)
Our protocol tests bavi/doce vs. doce alone.
What FDA approved treatments for 2nd-line NSCLC have the best survival times?
How do they stack up in safety and tolerability?
July 12, 2012 Peregrine webcast: MOS numbers in 2nd-line NSCLC in for control arm <6mos but not yet evented for treatment arm. PPHM reported control arm on May 21, 2012.
Webcast
http://wsw.com/webcast/jmp18/register.aspx?conf=jmp18&page=pphm&url=http%3A//wsw.com/webcast/jmp18/pphm/
From the May PR for 2nd-Line NSCLC, top-line data:
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=675168
Another secondary endpoint, median overall survival (OS), in the control arm has already been determined at less than 6 months, while the median has not been reached in either bavituximab-containing arm.
Based on independent radiology reviews and current status of patients, top-line data from the trial are as follows (notes added for clarity because of formatting problems):
----------------------------------------------------------------------------
Overall Response Rate (ORR)
7.9% (Docetaxel alone)
15.0% (Docetaxel plus Bavi lower-dose)
17.9% (Docetaxel plus Bavi higher-dose)
----------------------------------------------------------------------------
Median Progression-Free Survival (PFS)
3.0 months (Docetaxel alone)
4.2 months (Docetaxel plus Bavi lower-dose)
4.5 months (Docetaxel plus Bavi higher-dose)
----------------------------------------------------------------------------
During today's JMP webcast, PPHM said that neither treatment arm has yet evented for MOS.
April is when they unblinded. The MOS could have evented for the control arm before unblinding.
lol... :o)
It's like watching the fireworks on the 4th of July ... pretty amazing.
Big resistance line. .91 was our support since a little before the topline, 1st line data release. We dropped below it 3/5 with the bottomline release.
They removed it? Oh man. That was my best post ever...
VNGM up 33%
JCTCF up 24%
AFFY up 20%
PPHM up 19.74%
Two suggestions:
Don't go up on margin. A big drop (the market is dirty) will take your shares and maybe even your house and family.
Don't use stop losses. If the potential is enormous, so will be the effort to pry your shares out of your hands. Expect BIG volitility. In Dendreon there was a bear attack that sent the stock from the 20s, I believe, all the way to 7 dollars in just a few seconds. People with stoplosses set at 15 dollars, 12 dollars, even 10 dollars had their shares taken away at 7 dollars. If the best price you can get is way below your stop loss, you will be filled at that low price.
Better to protect yourself with puts.
Shareholder of Elan and Dendreon. Been there, done that.
Have we heard anything regarding whether or not the arms of the NSCLC PII trials were well balanced?
My new calc: 7/23 we will reach 100% improvement over the SOC.
Hope FTM is right...! (We'd be ovedr 100% already.)